A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)
NCT ID: NCT05261126
Last Updated: 2024-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
381 participants
INTERVENTIONAL
2022-03-10
2022-11-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Enclitide Chloride 6 mg
Participants will receive 6 mg of enlicitide chloride orally QD for 8 weeks
Enclitide Chloride
Enclitide Chloride administered orally
Enclitide Chloride 12 mg
Participants will receive 12 mg of enlicitide chloride orally QD for 8 weeks
Enclitide Chloride
Enclitide Chloride administered orally
Enclitide Chloride 18 mg
Participants will receive 18 mg of enlicitide chloride orally QD for 8 weeks
Enclitide Chloride
Enclitide Chloride administered orally
Enclitide Chloride 30 mg
Participants will receive 30 mg of enlicitide chloride orally QD for 8 weeks
Enclitide Chloride
Enclitide Chloride administered orally
Placebo
Participants will receive enlicitide chloride-matching placebo orally QD for 8 weeks
Placebo
Placebo matching enclitide chloride administered orally
Interventions
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Enclitide Chloride
Enclitide Chloride administered orally
Placebo
Placebo matching enclitide chloride administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment with a stable dose of one or more lipid-lowering therapies for ≥30 days before screening, or has not received treatment with any lipid-lowering therapy for ≥30 days before screening.
* A female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and for at least 8 weeks after the last dose of study intervention.
Exclusion Criteria
* History of nephrotic syndrome.
* History of unstable angina, a myocardial infarction, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Screening.
* Has poorly controlled diabetes mellitus, defined as hemoglobin A1C (A1C) ≥9.0% at Screening.
* History of malignancy ≤3 years before screening, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, which have no timeframe limitations relative to screening.
* Currently participating in or has previously participated in an interventional clinical study within 3 months before Screening.
* Has moderate or greater renal insufficiency.
18 Years
80 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Westside Medical Associates of Los Angeles ( Site 0026)
Beverly Hills, California, United States
Clinical Trials Research ( Site 0007)
Sacramento, California, United States
National Research Institute (NRI) - Santa Ana ( Site 0024)
Santa Ana, California, United States
Excel Medical Clinical Trials ( Site 0042)
Boca Raton, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0050)
Coral Gables, Florida, United States
ForCare Clinical Research ( Site 0017)
Tampa, Florida, United States
Healthcare Research Network - Chicago ( Site 0037)
Flossmoor, Illinois, United States
Midwest Institute For Clinical Research ( Site 0036)
Indianapolis, Indiana, United States
Cotton O'Neil Mulvane ( Site 0022)
Topeka, Kansas, United States
L-MARC Research Center ( Site 0003)
Louisville, Kentucky, United States
The University of Mississippi Medical Center-Clinical Research and Trials Unit ( Site 0028)
Jackson, Mississippi, United States
Jubilee Clinical Research ( Site 0047)
Las Vegas, Nevada, United States
New Mexico Clinical Research & Osteoporosis Center ( Site 0032)
Albuquerque, New Mexico, United States
Mid Hudson Medical Research ( Site 0004)
New Windsor, New York, United States
altoona center for clinical research ( Site 0045)
Duncansville, Pennsylvania, United States
Piedmont Research Partners ( Site 0005)
Fort Mill, South Carolina, United States
Dallas Diabetes Research Center ( Site 0012)
Dallas, Texas, United States
Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0051)
Houston, Texas, United States
Northeast Clinical Research of San Antonio ( Site 0014)
San Antonio, Texas, United States
National Clinical Research, Inc-research office ( Site 0019)
Richmond, Virginia, United States
Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0504)
München, Bavaria, Germany
Kardiologische Gemeinschaftspraxis ( Site 0502)
Nuremberg, Bavaria, Germany
Ambulantes Herzzentrum Kassel ( Site 0501)
Kassel, Hesse, Germany
Universitätsklinikum Leipzig ( Site 0500)
Leipzig, Saxony, Germany
Charité Campus Virchow-Klinikum ( Site 0505)
Berlin, , Germany
Chubu Rosal Hospital ( Site 1612)
Nagoya, Aichi-ken, Japan
Kyoto Okamoto Memorial Hospital ( Site 1611)
Kuse-gun Kumiyama-cho, Kyoto, Japan
Kitada Clinic ( Site 1604)
Osaka, Osaka, Japan
Medical Corporation Heishinkai OCROM Clinic ( Site 1600)
Suita-shi, Osaka, Japan
Seiwa Clinic ( Site 1605)
Adachi-ku, Tokyo, Japan
meiwa hospital ( Site 1602)
Chiyoda-ku, Tokyo, Japan
Heishinkai Medical Group ToCROM Clinic ( Site 1601)
Shinjuku-ku, Tokyo, Japan
Sekino Hospital ( Site 1603)
Toshimaku, Tokyo, Japan
Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 0205)
Guadalajara, Jalisco, Mexico
Unidad de Investigaci�n Cl�nica Cardiometabolica de Occident-Unidad de Investigación Clínica Cardio
Guadalajara, Jalisco, Mexico
Bio Investigación AMARC, S.C. ( Site 0204)
Mexico City, Mexico City, Mexico
Hospital Angeles Mocel ( Site 0209)
Mexico City, Mexico City, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0212)
Mexico City, Mexico City, Mexico
Unidad biomedica avanzada monterrey-Clinical Trials ( Site 0200)
Monterrey, Nuevo León, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares-Subinvestigation ( Site 0201)
Ciudad Madero, Tamaulipas, Mexico
Hospital Angeles Xalapa-Internal Medicine-Cardiology ( Site 0202)
Xalapa, Veracruz, Mexico
Medical Care and Research SA de CV ( Site 0211)
Mérida, Yucatán, Mexico
Centro de Atención e Investigación Clínica ( Site 0214)
Aguascalientes, , Mexico
Akershus Universitetssykehus-Hjertemedisinsk Avdeling ( Site 0705)
Lørenskog, Akershus, Norway
Nordlandssykehuset ( Site 0709)
Bodø, Nordland, Norway
Stavanger Universitetssykehus ( Site 0706)
Stavanger, Rogaland, Norway
Sykehuset i Vestfold-Hjerteseksjonen ( Site 0703)
Tønsberg, Vestfold, Norway
Oslo Universitetssykehus Aker-Preventiv kardiologi Aker ( Site 0704)
Oslo, , Norway
Oslo Universitetssykehus Rikshospitalet-Kardiologisk avdeling ( Site 0702)
Oslo, , Norway
Oslo Universitetssykehus Ullevål-Hjertemedisinsk avdeling, Ullevål ( Site 0701)
Oslo, , Norway
Oslo Universitetssykehus Aker-Lipidklinikken ( Site 0700)
Oslo, , Norway
Keimyung University Dongsan Hospital ( Site 1703)
Daegu, Taegu-Kwangyokshi, South Korea
Seoul National University Hospital ( Site 1702)
Seoul, , South Korea
Severance Hospital, Yonsei University Health System ( Site 1701)
Seoul, , South Korea
Samsung Medical Center ( Site 1700)
Seoul, , South Korea
Ege University Medicine of Faculty-Cardilogy Department ( Site 1003)
Bornova, İzmir, Turkey (Türkiye)
Hacettepe Universitesi ( Site 1002)
Ankara, , Turkey (Türkiye)
Eskisehir Osmangazi University-Cardiology ( Site 1000)
Eskişehir, , Turkey (Türkiye)
Royal Free Hospital ( Site 1311)
London, England, United Kingdom
Queen Elizabeth University Hospital-Glasgow Clinical Research Facility ( Site 1310)
Glasgow, Glasgow City, United Kingdom
Layton Medical Centre ( Site 1303)
Blackpool, Lancashire, United Kingdom
William Harvey Heart Centre ( Site 1308)
London, London, City of, United Kingdom
Walsall Manor Hospital ( Site 1309)
West Midlands, Walsall, United Kingdom
Countries
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References
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Ballantyne CM, Banka P, Mendez G, Garcia R, Rosenstock J, Rodgers A, Mendizabal G, Mitchel Y, Catapano AL. Phase 2b Randomized Trial of the Oral PCSK9 Inhibitor MK-0616. J Am Coll Cardiol. 2023 Apr 25;81(16):1553-1564. doi: 10.1016/j.jacc.2023.02.018. Epub 2023 Mar 6.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-0616-008
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031210701
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-005221-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
0616-008
Identifier Type: -
Identifier Source: org_study_id